NCT03716232

Kaffes Stent in the Management of Post-surgical Biliary Strictures

Status unknown Phase 3 Last updated 17 March 2020

What this trial tests

Phase 3 trial testing Metallic stent in Benign Biliary Stricture in 30 participants. Status unknown.

Timeline

1 July 2018

Primary endpoint
31 July 2020

31 December 2020

Quick facts

Lead sponsor	Cairo University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 July 2018
Primary completion	31 July 2020
Estimated completion	31 December 2020
Sites	3 locations across Egypt

Drugs / interventions tested

• Metallic stent
• Multiple plastic stents

Conditions studied

• Benign Biliary Stricture — all drugs for Benign Biliary Stricture →
• Biliary Stricture — all drugs for Biliary Stricture →
• Cholangitis — all drugs for Cholangitis →
• Bile Duct Stricture — all drugs for Bile Duct Stricture →

Sponsor

Cairo University

Who can join

Adults 18 to 65, any sex, with Benign Biliary Stricture or Biliary Stricture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Post-surgical biliary strictures are common especially after cholecystectomy. Standard treatment involves the performance of multiple procedures over a 1 year period at least using several plastic stents to achieve permanent dilatation of these strictures.

Metallic stents have the theoretical benefit of absence of need of multiple sessions.

These strictures however are frequently very close to the hilum and thus previously considered a contraindication for insertion of metallic stents for the fear of occlusion of the contralateral ducts. Metallic stent migration is also a frequent problem.

The use of a metallic stent that is short and completely intraductal, in theory, should reduce the risk of stent migration.

This is a randomized controlled trial comparing the efficacy and safety of a short metallic intraductal stent to the conventional treatment which is multiple plastic stents. In cases with a stricture reaching or close to the hilum a technique is used to avoid obstruction of the contralateral ducts which is insertion of a 7 French plastic stent alongside the metallic stent.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.